Post-market issues covered by two new draft guidelines from FDA

The US Food and Drug Administration (FDA) has published two new draft guidance documents for public comment before 26 July 2021.

The first is titled ‘Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act: Draft Guidance for Industry and Food and Drug Administration Staff’, available from here. This draft explains that Section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) provides FDA with the authority to require manufacturers to conduct postmarket surveillance at the time of approval or clearance or at any time thereafter of certain class II or class III devices. Postmarket surveillance is the active, systematic, scientifically valid collection, analysis, and interpretation of data or other information about a marketed device. The data collected under such a ‘surveillance order’ may help to address important public health questions on the safety and effectiveness of a device.

According to FDA, this draft guidance, when finalized, will assist manufacturers of devices subject to section 522 postmarket surveillance orders by providing:

• an overview of section 522 of the FD&C Act;
• information on how to fulfill section 522 obligations, including:
  • when postmarket surveillance should be considered commenced;
  • recommendations for achieving an approved postmarket surveillance plan in a timely manner; and
  • recommendations for enrollment schedules to help achieve timely completion of postmarket surveillance;
• recommendations on the format, content, and review of postmarket surveillance plan and report submissions, including revised FDA review times for postmarket surveillance-related submissions; and
• updated surveillance status categories to better reflect progress.

FDA adds that: “This draft guidance document also aims to increase transparency to stakeholders on FDA’s approach to the issuance and tracking of 522 postmarket surveillance orders, and expectations for timely study completion. Our initiative to increase transparency includes posting the manufacturers’ progress on addressing section 522 orders on FDA’s website.”

The second draft is titled ‘Procedures for Handling Post-Approval Studies Imposed by Premarket Approval Application Order: Draft Guidance for Industry and Food and Drug Administration Staff’, available from here. To provide reasonable assurance, or the continued assurance, of safety and effectiveness of an approved device, FDA may require a post-approval study (PAS) as a condition of approval in a PMA approval order. FDA explains that a PAS is usually a clinical or non-clinical study, typically intended to gather specific data to address questions about the postmarket performance of or experience with an approved medical device.

As described in “Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval”, FDA may consider it acceptable to collect certain data in the postmarket setting, rather than premarket under certain circumstances when FDA has uncertainty regarding certain benefits or risks of the device, but the degree of uncertainty is acceptable in the context of the overall benefit-risk profile of the device.

According to FDA, the purpose of the draft guidance when finalized, is to assist stakeholders with understanding PAS requirements imposed as a condition of PMA approval by providing:

• procedural information;
• recommendations concerning the format, content, and review of PAS-related submissions; and
• updates to the final guidance entitled “Procedures for Handling Post-Approval Studies Imposed by PMA Order”, dated June 2009, including:
  • recommendations to help facilitate FDA’s review of a PAS protocol in a timely manner;
  • recommendations for study timelines including enrollment milestones and study completion;
  • revised definitions to PAS status categories that FDA believes better reflect progress of the PAS; and
  • revised FDA review time goals for PAS-related submissions.